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本文用体外试验法,研究苯妥英钠片及胶囊的不同批号商品,在不同湿度的贮存过程中,释药速率的变化。实验采用批号不同的两批苯妥英钠片及胶囊,分别以片B_1、片B_2、胶囊A_1、胶囊A_2表示。将片及胶囊以原包装形式,贮存于相对湿度为56、75和95%的干燥器中,定期2、4、8周,用USP/NF 第20版的转篮法,测定该四种制剂中苯妥英钠的溶出速率。
In this paper, in vitro test method, phenytoin sodium tablets and capsules of different batches of goods, storage in different humidity during the release rate changes. Two batches of different batches of phenytoin tablets and capsules were used in the experiment, which were expressed as tablets B_1, tablets B_2, capsules A_1 and capsules A_2, respectively. The tablets and capsules were stored in their original packaging in desiccators at 56, 75 and 95% relative humidity for two, four and eight weeks on a regular basis using the USP / NF 20th edition spin-on method to determine the four formulations The dissolution rate of phenytoin sodium.